CN110279658A - A kind of oxytocin injection and preparation method thereof - Google Patents
A kind of oxytocin injection and preparation method thereof Download PDFInfo
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- CN110279658A CN110279658A CN201910720142.8A CN201910720142A CN110279658A CN 110279658 A CN110279658 A CN 110279658A CN 201910720142 A CN201910720142 A CN 201910720142A CN 110279658 A CN110279658 A CN 110279658A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A61K38/095—Oxytocins; Vasopressins; Related peptides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/04—Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
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Abstract
The invention discloses a kind of oxytocin injection, the component comprising following content: 10 units of oxytocin/mL, benzyl alcohol 0.1-1%w/v, 100~300 units of vitamin E/ml, pH adjusting agent, surplus are water for injection；The PH regulator is used to adjust the pH value of injection, and the dosage of pH adjusting agent, which is subject to, adjusts the pH value of injection to 3.8 ± 0.5.The preparation method of the oxytocin injection, comprising the following steps: prepare raw material by recipe quantity, be packed into water for injection in a reservoir, oxytocin, benzyl alcohol and vitamin E are added in water for injection and are stirred evenly, after static a period of time, pH to 3.8 ± 0.5 is adjusted with pH adjusting agent, then with water for injection constant volume, stirring 30 minutes, then pass through sterilising filter filtering, then filling in ampoule bottle, sealing, sterilizing, obtains oxytocin injection.The oxytocin injection good stability, high-quality, drug effectiveness ideal, suitable for industrialization production.
Description
Technical field
The invention belongs to veterinary drug technical field, in particular to a kind of oxytocin injection and preparation method thereof.
Background technique
During Livestock Production, production efficiency is improved, production cost is reduced, is the target that aquaculture is pursued always.And divide
Childbirth is an important link in cattle breeding reproductive process.In modern aquaculture model, the generally existing dam of birth process point
The problems such as childbirth is powerless, stages of labor is too long, postpartum hemorrhage, causes to seriously endanger to the life security of dam and newborn animal, gives animal farm
Serious economic loss is brought, the development of animal husbandry is influenced.
Therefore, it is necessary to develop a kind of drug for the problem during Livestock Production, to reinforce domestic animal uterus receipts
Contracting prevents postpartum hemorrhage, effectively shortens stages of labor.In the prior art, the drug ingedient stability for contracting palace is poor, using effect
Difference, and it is unfavorable for industrialization production.
Summary of the invention
In order to solve the above technical problems, the purpose of the present invention is to provide a kind of oxytocin injection and preparation method thereof,
The oxytocin injection good stability, high-quality, drug effectiveness ideal, suitable for industrialization production.
To realize above-mentioned technical purpose and the technique effect, the invention is realized by the following technical scheme: a kind of contracting
Palace element injection, the component comprising following content: 10 units of oxytocin/mL, the unit are medicine potency unit (international unit),
Benzyl alcohol 0.1-1%w/v, 00~300 unit of vitamin e1/ml, the unit are also medicine potency unit (international unit), pH tune
Agent is saved, surplus is water for injection；
The PH regulator is used to adjust the pH value of injection, and the dosage of pH adjusting agent is to adjust the pH value of injection to 3.8
Subject to ± 0.5.
Preferably, the pH adjusting agent is 1mol/L sodium hydroxide solution.
Preferably, which includes the component of following content: 10 units of oxytocin/mL, benzyl alcohol 0.1%w/
V, 00 unit of vitamin e1/ml, pH adjusting agent, surplus are water for injection；The dosage of pH adjusting agent is to adjust the pH value of injection
To subject to 3.8 ± 0.5.
The present invention also provides the preparation methods of the oxytocin injection, comprising the following steps:
Prepare raw material by recipe quantity, is packed into water for injection in a reservoir, oxytocin, benzyl alcohol and vitamin E are added to
It in water for injection and stirs evenly, after static a period of time, adjusts pH to 3.8 ± 0.5 with pH adjusting agent, then fixed with water for injection
Hold, stir 30 minutes, then passes through sterilising filter filtering, it is then filling in ampoule bottle, it seals, sterilizing, obtains oxytocin note
Penetrate liquid.
Preferably, in the above preparation method, the temperature of the water for injection is 30 DEG C or less.
Preferably, in the above preparation method, after oxytocin, benzyl alcohol and vitamin E being added to water for injection, stirring
15 minutes, static 10 minutes.
Preferably, in the above preparation method, the condition of the sterilizing are as follows: sterilize 20~40min at 90~110 DEG C.
Preferably, which further includes ampoule bottle treatment process, the process are as follows: ampoule bottle is first utilized water for injection
It is cleaned through ultrasonic cleaning machine, then sterilizing is dried under the conditions of 310~330 DEG C of temperature.
Preferably, in the above preparation method, the filtering accuracy of the sterilising filter is 0.22um.
It preferably, in the above preparation method, is twice using the number that sterilising filter is filtered.
The beneficial effects of the present invention are: the main component of oxytocin injection of the invention is oxytocin, benzyl alcohol, dimension life
Plain E, water for injection and pH adjusting agent avoid complicated component from influencing main function wherein not adding other extra ingredients.
Oxytocin in injection of the invention is the annular of posterior pituitary tissue that is artificial synthesized or being derived from healthy domestic animal
Nonapeptide hormone, amino acid sequence are L- cysteinyl-L- tyrosyl-L- isoleucyl- L-Glutamine acyl-L- asparagine acyl-
L- cysteinyl-L- dried meat ammonia matches-L leucyl-L- glycine amide ring (1-6) disulphide, has in viviparous mammal
The effect of uterine contraction and lactation is stimulated, has and hastens parturition and promote milk ejection and other effects, and postpartum uterine hemorrhage can be prevented, avoid
Afterbirth is unstable.
Vitamin E in injection of the invention cooperates oxytocin, so that drug using effect is more preferably；Benzene first therein
Alcohol can locally relieve the pain when injection；Each component cooperation in injection of the invention, generates synergistic effect, greatly improves
Using effect and liquid medicine stability.Injection of the invention can carry out filling capacity regulating according to practical application, be suitable for industrialization
Production；
Preparation method of the invention is simple, easy to operate, it can be achieved that sterile production, stable product quality obtained, and can fit
For industrialized production.
Specific embodiment
The preferred embodiments of the present invention will be described in detail below so that advantages and features of the invention can be easier to by
It will be appreciated by those skilled in the art that so as to make a clearer definition of the protection scope of the present invention.
Embodiment
EmbodimentFor the formulation Example of oxytocin injection；Wherein oxytocin as described below and vitamin E
Unit is medicine potency unit (international unit).
Embodiment 1
- kind of oxytocin injection, the component including following content: 10 units of oxytocin/mL, benzyl alcohol 0.1%w/v, dimension
Raw element E100 unit/mL, concentration are the sodium hydroxide solution of 1mol/L, Yu Chongwei water for injection；Wherein, concentration is 1mol/L's
The dosage of sodium hydroxide solution, which is subject to, adjusts the pH value of injection to 3.8 ± 0.5.
Embodiment 2
- kind of oxytocin injection, the component including following content: 10 units of oxytocin/mL, benzyl alcohol 0.5%w/v, dimension
Raw 200 units of element E/mL, concentration are the sodium hydroxide solution of 1mol/L, Yu Chongwei water for injection；Wherein, concentration 1mol/L
The dosage of sodium hydroxide solution be subject to and adjust the pH value of injection to 3.8 ± 0.5.
Embodiment 3
- kind of oxytocin injection, the component including following content: 10 units of oxytocin/mL, benzyl alcohol 1%w/v, dimension life
Plain 300 units of E/mL, concentration are the sodium hydroxide solution of 1mol/L, Yu Chongwei water for injection；Wherein, concentration is 1mol/L's
The dosage of sodium hydroxide solution, which is subject to, adjusts the pH value of injection to 3.8 ± 0.5.
Dissolution comparison by Examples 1 to 3 will be tieed up to guarantee benzyl alcohol and vitamin E better solubility in water
The optimum amount of raw element E is determined as 100 units/mL, and the optimum amount of benzyl alcohol is determined as (the contracting palace of every 1000ml 0.1%w/v
Contain the benzyl alcohol of 1g in plain injection).
Embodiment 4~6 is the wash bottle embodiment in the preparation method of oxytocin injection.
Embodiment 4
Ampoule bottle is got, outsourcing is taken off, between being sent into wash bottle after pass-through box sterilizes 30 minutes, first with water for injection through ultrasound
The cleaning of wave cleaning robot, then the conveyer belt through walking speed 50Hz enter the tunnel sterilization baking oven that bringing-up section temperature is 310 DEG C and are done
Dry sterilizing.
Embodiment 5
Ampoule bottle is got, outsourcing is taken off, between being sent into wash bottle after pass-through box sterilizes 30 minutes, first with water for injection through ultrasound
The cleaning of wave cleaning robot, then the conveyer belt through walking speed 50Hz enter the tunnel sterilization baking oven that bringing-up section temperature is 320 DEG C and are done
Dry sterilizing.
Embodiment 6
Ampoule bottle is got, outsourcing is taken off, between being sent into wash bottle after pass-through box sterilizes 30 minutes, first with water for injection through ultrasound
The cleaning of wave cleaning robot, then the conveyer belt through walking speed 50Hz enter the tunnel sterilization baking oven that bringing-up section temperature is 330 DEG C and are done
Dry sterilizing.
The ampoule bottle after sterilizing in embodiment 4-6 is through examining microorganism, and drying is gone out in 320 DEG C of tunnel sterilization baking oven
The ampoule bottle process conditions of bacterium are best, no microorganism detection.Determine the ampoule bottle processing in the preparation method of oxytocin injection
Process are as follows: first ampoule bottle is cleaned using water for injection through ultrasonic cleaning machine, then 320 DEG C at a temperature of be dried and go out
Bacterium.
Embodiment 7
By the best composition and recipe quantity preparation raw material components in embodiment 1, by ampoule bottle using water for injection through ultrasound
The cleaning of wave cleaning robot, then sterilizing is dried at a temperature of 320 DEG C.The cooling for accounting for total amount 70% is packed into suitable container
To 30 DEG C of waters for injection below, oxytocin, benzyl alcohol and vitamin E are added in water for injection, and stirred 15 minutes, is made
Each component is uniformly mixed, static to adjust pH to 3.3 with the sodium hydroxide solution of 1mol/L after ten minutes, then with being cooled to 30
DEG C water for injection constant volume below stirs 30 minutes, then passes through 0.22 μm of sterilising filter filtering twice, then filling in peace
In small jar bottle, sealing.
Embodiment 8
By the best composition and recipe quantity preparation raw material components in embodiment 1, by ampoule bottle using water for injection through ultrasound
The cleaning of wave cleaning robot, then sterilizing is dried at a temperature of 320 DEG C.The cooling for accounting for total amount 70% is packed into suitable container
To 30 DEG C of waters for injection below, oxytocin, benzyl alcohol and vitamin E are added in water for injection, and stirred 15 minutes, is made
Each component is uniformly mixed, static to adjust pH to 3.6 with the sodium hydroxide solution of 1mol/L after ten minutes, then with being cooled to 30
DEG C water for injection constant volume below stirs 30 minutes, then passes through 0.22 μm of sterilising filter filtering twice, then filling in peace
In small jar bottle, sealing.
Embodiment 9
By the best composition and recipe quantity preparation raw material components in embodiment 1, by ampoule bottle using water for injection through ultrasound
The cleaning of wave cleaning robot, then sterilizing is dried at a temperature of 320 DEG C.The cooling for accounting for total amount 70% is packed into suitable container
To 30 DEG C of waters for injection below, oxytocin, benzyl alcohol and vitamin E are added in water for injection, and stirred 15 minutes, is made
Each component is uniformly mixed, static to adjust pH to 3.9 with the sodium hydroxide solution of 1mol/L after ten minutes, then with being cooled to 30
DEG C water for injection constant volume below stirs 30 minutes, then passes through 0.22 μm of sterilising filter filtering twice, then filling in peace
In small jar bottle, sealing.
Embodiment 10
By the best composition and recipe quantity preparation raw material components in embodiment 1, by ampoule bottle using water for injection through ultrasound
The cleaning of wave cleaning robot, then sterilizing is dried at a temperature of 320 DEG C.The cooling for accounting for total amount 70% is packed into suitable container
To 30 DEG C of waters for injection below, oxytocin, benzyl alcohol and vitamin E are added in water for injection, and stirred 15 minutes, is made
Each component is uniformly mixed, static to adjust pH to 4.2 with the sodium hydroxide solution of 1mol/L after ten minutes, then with being cooled to 30
DEG C water for injection constant volume below stirs 30 minutes, then passes through 0.22 μm of sterilising filter filtering twice, then filling in peace
In small jar bottle, sealing.
To embodimentOxytocin injection in the ampoule bottle of preparation carries out potency comparison, result such as 1 institute of table
Show.
1 embodiment of tableThe oxytocin injection potency of preparation compares
Embodiment 11
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 20min under the conditions of 90 DEG C of temperature.
Embodiment 12
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 30min under the conditions of 90 DEG C of temperature.
Embodiment 13
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 40min under the conditions of 90 DEG C of temperature.
Embodiment 14
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 20min under the conditions of 100 DEG C of temperature.
Embodiment 15
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 30min under the conditions of 100 DEG C of temperature.
Embodiment 16
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 40min under the conditions of 100 DEG C of temperature.
Embodiment 17
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 20min under the conditions of 110 DEG C of temperature.
Embodiment 18
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 30min under the conditions of 110 DEG C of temperature.
Embodiment 19
The ampoule bottle for being filled with oxytocin injection prepared by Example 8, carries out sterilization treatment, sterilising conditions to it
Are as follows: sterilize 40min under the conditions of 110 DEG C of temperature.
To embodimentOxytocin injection after sterilizing carries out content and sterilization effect compares, and the result is shown in tables
2。
Oxytocin injection content and sterilization effect comparison result after the sterilizing of 2 embodiment 11~19 of table
To embodimentOxytocin injection content and sterilization effect in ampoule bottle after sterilizing are compared,
It sterilizes under the conditions of 90 DEG C of temperature, sterilization effect is not achieved, sterilize under the conditions of 110 DEG C of temperature, sterilizing temperature
Degree is high, and oxytocin injection percentage composition is decreased obviously, and relative substance content rises.
The result of embodiment 15 is most stable, and sterilization effect is good.
The optimization formula of oxytocin injection can be obtained according to the comparative test of the above various embodiments are as follows:
A kind of oxytocin injection, the component comprising following content:
10 units of oxytocin/mL,
Benzyl alcohol 0.1%w/v,
00 unit of vitamin e1/ml,
PH adjusting agent,
Surplus is water for injection；
Wherein, the dosage of pH adjusting agent should adjust the pH value of injection to 3.8 ± 0.5.
The oxytocin injection optimal the preparation method comprises the following steps:
Prepare raw material components by recipe quantity, ampoule bottle is cleaned through water for injection through ultrasonic cleaning machine, then at 320 DEG C
At a temperature of sterilizing is dried, in a reservoir be packed into be cooled to 30 DEG C of waters for injection below, by oxytocin, benzyl alcohol and Wei Sheng
Plain E is added in water for injection, and stir 15 minutes, make each component be uniformly mixed, it is static after ten minutes, with pH adjusting agent tune
PH to 3.6 ± 0.3 is saved, then with 30 DEG C of water for injection constant volumes below are cooled to, stir 30 minutes, then passes through 0.22 μm of sterilizing
Filter filters twice, then filling in ampoule bottle, and sealing, sterilize 30min under the conditions of 100 DEG C of temperature, after must sterilizing
Oxytocin injection.
The above description is only an embodiment of the present invention, is not intended to limit the scope of the invention, all to utilize this hair
Equivalent structure or equivalent flow shift made by bright description is applied directly or indirectly in other relevant technology necks
Domain is included within the scope of the present invention.
Claims (10)
1. a kind of oxytocin injection, which is characterized in that the component comprising following content: 10 units of oxytocin/mL, benzyl alcohol
0.1-1%w/v, 00~300 unit of vitamin e1/ml, pH adjusting agent, surplus are water for injection；
The PH regulator is used to adjust the pH value of injection, and the dosage of pH adjusting agent is to adjust the pH value of injection to 3.8 ± 0.5
Subject to.
2. a kind of oxytocin injection according to claim 1, which is characterized in that the pH adjusting agent is 1mol/L hydrogen-oxygen
Change sodium solution.
3. a kind of oxytocin injection according to claim 1, which is characterized in that the component comprising following content: contracting palace
Element 10 units/mL, benzyl alcohol 0.1%w/v, 00 unit of vitamin e1/ml, pH adjusting agent, surplus is water for injection；PH adjusting agent
Dosage be subject to and adjust the pH value of injection to 3.8 ± 0.5.
4. a kind of preparation method of oxytocin injection as described in any one of claims 1 to 3, which is characterized in that including with
Lower step:
Prepare raw material by recipe quantity, is packed into water for injection in a reservoir, oxytocin, benzyl alcohol and vitamin E are added to injection
With in water and stirring evenly, after static a period of time, pH to 3.8 ± 0.5 is adjusted with pH adjusting agent, then with water for injection constant volume,
Stirring 30 minutes then passes through sterilising filter filtering, then filling in ampoule bottle, seals, sterilizing, obtains oxytocin injection
Liquid.
5. the preparation method of oxytocin injection according to claim 4, which is characterized in that the temperature of the water for injection
It is 30 DEG C or less.
6. the preparation method of oxytocin injection according to claim 4, which is characterized in that by oxytocin, benzyl alcohol and
After vitamin E is added to water for injection, stir 15 minutes, static 10 minutes.
7. the preparation method of oxytocin injection according to claim 4, which is characterized in that the condition of the sterilizing are as follows:
?Lower sterilizing
8. the preparation method of oxytocin injection according to claim 4, which is characterized in that the preparation method further includes peace
Small jar bottle treatment process, the process are as follows: first ampoule bottle is cleaned using water for injection through ultrasonic cleaning machine, thenSterilizing is dried under the conditions of temperature.
9. the preparation method of oxytocin injection according to claim 4, which is characterized in that the mistake of the sterilising filter
Filter precision is 0.22um.
10. the preparation method of oxytocin injection according to claim 4, which is characterized in that using sterilising filter into
The number of row filtering is twice.
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| CN115475231A (en) * | 2022-09-30 | 2022-12-16 | 南京新百药业有限公司 | Preparation process of oxytocin injection and equipment for preparation process |
| CN115475231B (en) * | 2022-09-30 | 2023-09-08 | 南京新百药业有限公司 | Preparation process of oxytocin injection and equipment for preparation process |
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Application publication date: 20190927 |